There's
still time to tell an advisory committee what you think about genetic
testing and how these tests shouldor shouldn'tbe regulated
in the United States. The committee has completed a review of genetic
testing and will be recommending further oversight for all gene tests
in its final report later this year. A draft of the report has been posted
on the Internet for public comment until May 22, 2000.

The Secretary's Advisory Committee on Genetic Testing was created in
1998 by the Department of Health and Human Services to consider a range
of issues related to this new area of medicine. The chairman of the 13-member
panel is Edward McCabe, professor and chair of the department of pediatrics,
the University of California at Los Angeles.

The committee has gotten the message that people are concerned about
employers and insurance companies using genetic test results to discriminate
against them. This was a theme at a public meeting in Baltimore in January
and in some 400 messages the committee received through its office and
Web site. In February, President Clinton issued an executive order barring
the use of gene tests in the hiring or firing of federal employees.

The public's concerns are addressed in the report, "Adequacy of Oversight
of Genetic Tests." The committee writes: "Based on the rapidly evolving
nature of genetic tests, their anticipated widespread use, and extensive
concerns expressed by the public about their potential misuse or misinterpretation,
additional oversight is warranted for all genetic tests."

The committee is proposing that the Food and Drug Administration should
be the lead federal agency responsible for reviewing, approving, and labeling
all genetic tests. This would mean the agency would have to develop a
relatively efficient process for evaluating different kinds of tests,
since the report says that different tests warrant different oversight.
For instance, tests that predict a person's chances of developing a disease
require more scrutiny than do diagnostic tests, the committee writes.

At present genetic tests are available for roughly 300 diseases or conditions
through some 200 U.S. laboratories, and researchers are in the early stages
of developing several hundred more, according to GeneTests, a directory
of clinical laboratories providing tests for genetic disorders.

The Secretary's committee will meet June 5-7, 2000 to review the comments
received and develop a final report.

Below are five issues the committee has been considering since last summer.
In June, Assistant Secretary for Health and Surgeon General David Satcher
asked the committee to develop a report organized around these questions:

Issue 1: What criteria should be used to assess the benefits and risks
of genetic tests?

Issue 2: How can the criteria for assessing the benefits and risks of
genetic tests be used to differentiate categories of tests? What are the
categories, and what kind of mechanism could be used to assign tests to
the different categories?

Issue 3: What process should be used to collect, evaluate, and disseminate
data on single tests or groups of tests in each category?

Issue 4: What are the options for oversight of genetic tests and the
advantages and disadvantages of each option?

Issue 5: What is an appropriate level of oversight for each category
of genetic test?